Real-world outcomes of biosimilar bevacizumab-awwb versus reference bevacizumab in patients with metastatic colorectal cancer.

Abstract

3552 Background: Bevacizumab-awwb was the first biosimilar approved by the U.S. Food and Drug Administration (FDA) for treatment of cancer and became available for use in July 2019. Clinical comparative efficacy and safety of bevacizumab-awwb to bevacizumab was established in a single study of adult patients with advanced non-squamous non-small cell lung cancer. Approval based on extrapolation was granted by the FDA for all other indications, including metastatic colorectal cancer (mCRC). The objective of this study was to evaluate the real-world effectiveness and safety outcomes of patients with mCRC initiated on bevacizumab-awwb versus bevacizumab in an integrated healthcare delivery system. Methods: This was an observational cohort study of patients with mCRC in Kaiser Permanente California, Colorado, and Mid-Atlantic States who were initiated on bevacizumab-awwb between July 2019 and March 2020 or reference bevacizumab between July 2015 and June 2018. Patients with history of bevacizumab use in the 6 months prior to the index treatment date were excluded. Patients were followed until 12 months after treatment initiation, end of plan membership, or death, whichever occurred first. The primary outcome of overall survival (OS) was analyzed using a non-inferiority test with lower margin of 10% and Cox proportional-hazards modeling. Secondary outcomes included count of doses received, treatment duration, all-cause hospitalizations, and incidence of serious adverse events. Results: A total of 1,445 patients initiated on either bevacizumab-awwb (n=239) or bevacizumab (n=1,206) were included in the analysis. The mean overall age was 60 ± 13 years and 54% of patients were male. The OS rate was 72.8% and 73.1% for patients receiving bevacizumab-awwb and bevacizumab, respectively ( p<0.01 for non-inferiority). The adjusted hazard ratio for mortality was 1.01 (0.77-1.33, p=0.93). There were no statistically significant differences in secondary outcomes between the 2 study groups (Table). Conclusions: Bevacizumab-awwb is a safe and effective option when compared to the reference bevacizumab in the treatment of mCRC. Future studies should evaluate outcomes after longer follow-up time and in different cancer types. [Table: see text]

Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb)

“…12,34 Our results were also consistent with data from a most recent retrospective, non-inferiority cohort study of patients with mCRC in the United States that compared treatment outcomes of naïve patients initiating bevacizumab-awwb (n = 239) versus historical control group of naïve patients initiating RP (n = 1,206), which showed that one-year OS with bevacizumab-awwb (72.8%) was non-inferior to that with RP (73.1%). 35 EOIs reported in naïve patients and switchers during bevacizumab-awwb-containing treatment were also generally consistent with previously published data for mCRC patients treated with 1L RP [6][7][8][11][12][13]35 and consistent with adverse reactions described in bevacizumab-awwb labeling. 24 The aforementioned non-inferiority cohort study in mCRC patients confirmed that no significant differences in serious adverse events were detected between bevacizumabawwb and RP treatment groups.…”

“…Bevacizumab-awwb appeared to be well tolerated in both naïve patients and switchers, with observed EOIs as expected and similar to those of RP. [6][7][8][11][12][13]35 Effectiveness outcomes with bevacizumab-awwb in naïve patients were generally consistent with those reported in previously published real-world studies of 1L RP in patients with mCRC. 11,12,[34][35][36] In two US registry studies (ARIES and BRiTE), median PFS of ~10 months and median OS of ~23 months were reported in mCRC patients who had a median duration of 5 months of 1L RP use.…”

“…12,34 Our results were also consistent with data from a most recent retrospective, non-inferiority cohort study of patients with mCRC in the United States that compared treatment outcomes of naïve patients initiating bevacizumab-awwb ( n = 239) versus historical control group of naïve patients initiating RP ( n = 1,206), which showed that one-year OS with bevacizumab-awwb (72.8%) was non-inferior to that with RP (73.1%). 35…”

“…Bevacizumab-awwb appeared to be well tolerated in both naïve patients and switchers, with observed EOIs as expected and similar to those of RP. 6–8,11–13,35…”

“…Effectiveness outcomes with bevacizumab-awwb in naïve patients were generally consistent with those reported in previously published real-world studies of 1L RP in patients with mCRC. 11,12,34–36 In two US registry studies (ARIES and BRiTE), median PFS of ~10 months and median OS of ~23 months were reported in mCRC patients who had a median duration of 5 months of 1L RP use. 11,12 However, >80% of patients in these two US registry studies underwent surgical resection of primary tumor, 11,12 while only ~40% of patients in our study cohort had prior surgical resection.…”